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IMPORTANT: PLEASE READ
PART III:
CONSUMER INFORMATION
Zoladex®
goserelin depot
This leaflet is part III of a three-part "Product
Monograph" published when ZOLADEX®
was approved for sale in Canada and is designed
specifically for Consumers. This leaflet is a summary
and will not tell you everything about ZOLADEX.
Contact your doctor or pharmacist if you have any
questions about the drug.
ABOUT THIS MEDICATION
What ZOLADEX is used for:
Prostate Cancer
ZOLADEX is used:
 For the palliative treatment of patients with
hormone-dependent advanced carcinoma of the
prostate (Stage D2).
 In combination with a non-steroidal antiandrogen
and radiation therapy for the management of
locally advanced (T3, T4) or bulky Stage T2b, T2c
carcinoma of the prostate.
 As adjuvant hormone therapy to external beam
irradiation for patients with locally advanced
prostate cancer (Stage T3-T4).
Breast Cancer
ZOLADEX is used:
 As an alternative to standard adjuvant
chemotherapy in pre- and perimenopausal women
with early breast cancer who are unsuitable for,
intolerant to, or decline chemotherapy, and whose
tumour contains estrogen and/or progesterone
receptors.
 ZOLADEX is indicated for the palliative treatment
of advanced breast cancer in pre- and
perimenopausal women whose tumour contains
estrogen and/or progesterone receptors.
Benign Conditions
ZOLADEX is indicated for the hormonal management of
endometriosis, including pain relief and reduction of
endometriotic lesions. Experience with ZOLADEX for the
management of endometriosis has been limited to women 18
years of age and older, treated for 6 months.
ZOLADEX is indicated for use as an endometrial thinning
agent prior to endometrial ablation.
What ZOLADEX does:
ZOLADEX treatment, given once every 28 days, results in
suppression of your sex hormones (testosterone in men and
estradiol in women).
When ZOLADEX should not be used:
You should not use ZOLADEX if:
 You are allergic to goserelin acetate or any
nonmedicinal ingredients of in ZOLADEX.
 You are a woman who has abnormal vaginal bleeding
for an unknown reason.
 You are a woman who is pregnant.
 You are a woman who is breastfeeding.
What the medicinal ingredient is:
goserelin acetate
What the important nonmedicinal ingredients are:
Lactide-glycolide copolymer
What dosage forms ZOLADEX comes in:
ZOLADEX comes in a hard, cream-coloured, rod-shaped depot
which contains 3.6mg goserelin as goserelin acetate.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
ZOLADEX should be prescribed and managed by a
doctor experienced with using this type of drug.
ZOLADEX should be administered by a healthcare
professional experienced in administering deep
subcutaneous injections and under the supervision of a
physician.
ZOLADEX may cause:



Worsening of symptoms of prostate cancer at the
beginning of the treatment (risk of spinal cord
compression, or increased difficulty in urinating)
Bone thinning (osteoporosis)
Injection site injury (including damage to blood
vessels in the abdomen) has been reported
following injection of ZOLADEX. In rare cases
this has caused severe bleeding (with some cases
requiring surgical treatment).
If you go into hospital, let the medical staff know you are
receiving ZOLADEX.
In women, there are no clinical data on the effect of treating
endometriosis with ZOLADEX for periods in excess of 6
months.
ZOLADEX is not recommended for use in children.
ZOLADEX® Product Monograph
COPYRIGHT 2000-2016 ASTRAZENECA CANADA INC.
Page 1 of 4
IMPORTANT: PLEASE READ
ZOLADEX is not recommended for use in very thin patients
and/or those on blood thinners.
ZOLADEX is unlikely to affect your ability to drive a car or
to operate machinery.
Before you use ZOLADEX, talk to your doctor or
pharmacist if any of the following applies to you:
 Have or have had any problems passing urine.
 Family history of severe osteoporosis (thinning of
the bones with fractures).
 Have low bone mineral density (BMD).
 Taking other medicines that cause thinning of the
bones.
 Have a low red blood cell count (anemia)
 Have heart or blood vessel disease, have had an
abnormal heart rhythm (QT prolongation), have a
heart condition called ‘long QT syndrome’, a
family history of this heart condition, or are being
treated with medicines for these conditions.
ZOLADEX may increase the risk of having an
abnormal heart rhythm (QT prolongation).
 Have diabetes
 Are pregnant or planning to become pregnant.
ZOLADEX should not be used during pregnancy,
therefore, effective non-hormonal contraceptive
methods should be used to prevent pregnancy
during the treatment and until the return of menses
after the last injection with ZOLADEX. After
stopping ZOLADEX it may take longer for some
women to experience menses. Rarely, some
women may enter menopause. If 8 weeks have
passed after the last ZOLADEX injection and you
do not experience menses, talk to your doctor.
 Taking blood thinners.
INTERACTIONS WITH THIS MEDICATION
Check with your doctor or pharmacist before taking any
other drugs, including non-prescription drugs (for colds,
nausea, etc.). ZOLADEX might interfere with some
medicines used to treat heart rhythm problems or might
increase the risk of heart rhythm problems when used with
some other drugs that can cause heart rhythm abnormalities.
PROPER USE OF THIS MEDICATION
Usual Dose
 ZOLADEX is given as an injection under the skin
of the abdomen by a trained health care
professional, such as a doctor or nurse.
 Prostate or breast cancer: one injection every 28
days.
 Endometriosis: one injection every 28 days.
ZOLADEX® Product Monograph


It is very important your doctor checks your progress at
regular medical visits. Consult your doctor before you
decide to change your treatment.
If you need more information, ask your doctor.
Overdose
In case of drug overdose, contact a health care practitioner,
hospital emergency department or regional Poison Control
Centre immediately, even if there are no symptoms.
Missed Dose
If you missed your scheduled dose, contact your doctor for
advice.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
As with all medicines, side effects are sometimes experienced
with ZOLADEX.
Contact your doctor or pharmacist if you experience any of
these problems:
 Tingling in your fingers or toes.
 Psychiatric problems such as hallucinations, disordered
thoughts or personality change. These have
occasionally been reported.
 Injection site injury (including damage to blood vessels
in the abdomen) has been reported following injection
of ZOLADEX. This can cause severe bleeding. Contact
your doctor immediately if you experience any of the
following symptoms: bleeding underneath the skin or
bruising, abdominal pain, abdominal distension,
swelling at the injection site, shortness of breath,
dizziness, low blood pressure and/or any altered levels
of consciousness.
 There have been occasional reports of side effects with
pituitary tumours. You may develop a tumour of the
pituitary gland in your head or, if you have an existing
tumour of the pituitary gland, ZOLADEX may cause it
to bleed or collapse. Pituitary tumours may cause
headaches, vomiting, loss of eyesight and
unconsciousness.
 A local skin reaction may occur at the injection site
such as pain, bruising, bleeding, itching, redness,
burning and swelling. These reactions generally are
mild and disappear after a few days. If they get worse
or do not go away, tell your doctor.
 Cancer patients: Contact your doctor immediately if
you develop: severe increased pain, numbness or
weakness of the limbs, or persistent difficulty in
urinating (prostate cancer).
COPYRIGHT 2000-2016 ASTRAZENECA CANADA INC.
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IMPORTANT: PLEASE READ
Use of ZOLADEX in Men
 When you first start receiving ZOLADEX you may
feel some pain in your bones. If this happens tell
your doctor and you may be given something for
this.
 Very occasionally you may have trouble passing
urine or experience lower back pain. If this
happens, tell your doctor and you may be given
something for this.
 You may experience hair loss, particularly the loss
of body hair.
Use of ZOLADEX in Women
 For pre-menopausal women: menstruation stops
with the monthly depot of ZOLADEX. If regular
menstruation persists, notify your doctor. If a
monthly ZOLADEX depot is missed, breakthrough
menstrual bleeding may occur.
 Vaginal bleeding may occur. At the beginning of
treatment, if you have fibroids a slight increase in
symptoms, such as pain, may occur. These effects
are usually short-lived and discontinue on
continuation of treatment. If symptoms persist or
you are uncomfortable, contact your doctor.
 Occasionally some women may enter menopause
early, so when ZOLADEX treatment is stopped,
menstruation will not start again.
 ZOLADEX has been associated with the formation
of ovarian cysts, which may cause pain for some
women.
 If you experience excessive nausea, vomiting or
thirst, you should tell your doctor. This may
indicate possible changes in the amount of calcium
in your blood and your doctor may have to do
certain blood tests.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY
HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect
Talk with your
doctor or
pharmacist
Only if
severe
Tingling in fingers or toes
√
Changes in blood pressure
Skin rashes
In all
cases
√
√
Thinning of bones
√
Heart failure (reduced heart
function) or heart attack
√
Weight gain
Stop taking
drug and
call your
doctor or
pharmacist
√
Uncommon (1 to 10 in every 1000 patients are likely to have
them)
Tender breasts
√
Joint pain
√
Allergic reactions
√
Rare (1 to 10 in every 10 000 patients are likely to have them)
Severe bleeding due to
√
injection site injury, including
damage to blood vessels in the
abdomen. Symptoms such as
bleeding underneath the skin
or bruising, abdominal pain,
abdominal distension,
swelling at the injection site,
shortness of breath, dizziness,
low blood pressure and/or
altered levels of
consciousness.
USE OF ZOLADEX IN WOMEN
SERIOUS SIDE EFFECTS, HOW OFTEN THEY
HAPPEN AND WHAT TO DO ABOUT THEM
Very Common (more than 10 in every 100 patients are likely to
have them)
Reduced sex drive
√
Symptom / effect
Hot flushes and sweating
√
Vaginal dryness
√
Change in breast size
√
Injection site reaction
√
Acne*
√
Talk with your
doctor or
pharmacist
Only if
severe
In all
cases
Stop taking
drug and
call your
doctor or
pharmacist
USE OF ZOLADEX IN MEN
Common (1 to 10 in every 100 patients are likely to have them)
Very Common (more than 10 in every 100 patients are likely to
have them)
Increased signs and symptoms
of breast cancer
√
Reduced sex drive/impotence
√
√
Mood changes including
depression
√
Hot flushes and sweating
Common (1 to 10 in every 100 patients are likely to have them)
Change in breast size
√
Injection site reaction
√
Depression
Bone pain
Rises in blood sugar levels
ZOLADEX® Product Monograph
Tingling in fingers and toes
√
Headache
√
Changes in blood pressure
√
√
Skin rashes
Thinning of bones
√
√
Joint pain
√
√
COPYRIGHT 2000-2016 ASTRAZENECA CANADA INC.
√
Page 3 of 4
IMPORTANT: PLEASE READ
SERIOUS SIDE EFFECTS, HOW OFTEN THEY
HAPPEN AND WHAT TO DO ABOUT THEM
REPORTING SUSPECTED SIDE EFFECTS
Symptom / effect
You can report any suspected adverse reactions
associated with the use of health products to the Canada
Vigilance Program by one of the following 3 ways:
Talk with your
doctor or
pharmacist
Only if
severe
Hair loss (usually mild but
occasionally severe)
√
Weight gain
√
In all
cases
Stop taking
drug and
call your
doctor or
pharmacist
Uncommon (1 to 10 in every 1000 patients are likely to have
them)
Allergic reactions
√
Rare (1 to 10 in every 10 000 patients are likely to have them)
Severe bleeding due to
√
injection site injury, including
damage to blood vessels in the
abdomen. Symptoms such as
bleeding underneath the skin
or bruising, abdominal pain,
abdominal distension,
swelling at the injection site,
shortness of breath, dizziness,
low blood pressure and/or
altered levels of
consciousness.
* Often, acne is reported within one month after starting
ZOLADEX.
This is not a complete list of side effects. For any
unexpected effects while taking ZOLADEX, contact your
doctor or pharmacist.
HOW TO STORE IT



ZOLADEX should not be used after the expiry date
on the pack. Store ZOLADEX in its original pack
between 2°C and 25°C.
If your doctor decides to stop your treatment, return
ZOLADEX to the pharmacy for proper disposal.
Keep your ZOLADEX in a safe place where
children cannot reach it. It could harm them.
 Report online at www.healthcanada.gc.ca/medeffect
 Call toll-free at 1-866-234-2345
 Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting
Form and the adverse reaction reporting guidelines
are available on the MedEffect™ Canada Web site at
www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the
management of side effects, contact your health
professional. The Canada Vigilance Program does not
provide medical advice.
MORE INFORMATION
NOTE: This CONSUMER INFORMATION Leaflet provides
you with the most current information at the time of printing.
For the most current information, the Consumer Information
leaflet, plus the full Product Monograph prepared for health
professionals can be found at:
www.astrazeneca.ca,
or by contacting the sponsor, AstraZeneca Canada Inc. at:
Customer inquiries - 1-800-668-6000
Renseignements - 1-800-461-3787
This leaflet was prepared by:
AstraZeneca Canada Inc. Mississauga, Ontario L4Y 1M4
ZOLADEX® and the AstraZeneca logo are registered
trademarks of the AstraZeneca group of companies.
©
AstraZeneca 2000-2016
Last revised: August 08, 2016
ZOLADEX® Product Monograph
COPYRIGHT 2000-2016 ASTRAZENECA CANADA INC.
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